Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.
Cell Vitals Irvine, CA (11/24). Reviewed the firm’s Web site at www.cellvitals.com in September. Misbranded: Products appear to be promoted for uses that cause them to be drugs. The claims on the Web site indicate that the products are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or articles intended to affect the structure or any function of the human body, rendering them drugs under the Act. For example, under the “Skincare Tab” it states: “Camellia Sinesis Extract [an ingredient in your product]…is anti-bacterial and … anti-cancer,” etc. (ReLuma Advanced Stem Cell Facial Moisturizer, ReLuma Skin Illuminating Stem Cell Anti-Aging Cleanser, and ReLuma Stem Cell Eye Cream); FDCA 502(f)(1), 505(a)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm424920.htm
Greiner Bio One Brasil Produtos Americana, Brazil (8/8). Inspected 1/13-16. QSR deviations, adulterated: Procedures for design change have not been adequately established. The Vacuette collection tubes have specific requirements contained in the product labeling for shelf-life and maximum trace element content, but review of batch records revealed that the firm has not performed continuing testing in support of shelf life stability requirements or maximum permissible trace element content, etc. (Vacuette blood collection tubes); FDCA 501(h), 21 CFR 820.30(i), 820.30(g), 820.80(b), 820.22
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm424730.htm
Jansen Enterprises, LLC dba HealthWorksUSA Minnetonka, MN (11/24). Reviewed Web site at www.healthworksusa.net in November. Misbranded: The therapeutic claims establish that these products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. For example, on the cover of the corporate health manual: “Heal yourself of any disease.” The labeling fails to bear adequate directions for use, etc. (Nutra Blast Natural Energy, Ionic Silver Water, Nutra Complete, and Nutra Gel); FDCA 505(a), 502(f)(1)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm424910.htm
Long Island Pharmaceuticals, LLC Ronkonkoma, NY (11/20). Inspected 6/27-7/3. GMP deviations, adulterated: The firm failed to conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient prior to its use. The company response is inadequate because it stated that identity testing of raw materials will be on a random basis and assay of active ingredients will be on a rotating basis. FDA says the company must verify the identity of all components that are dietary ingredients before using them, unless it submits a petition to FDA for alternative testing, the agency grants the petition, and the company conducts tests and examinations under the terms FDA specifies when the petition is granted. Also, the company failed to develop and implement overall quality control operations and responsibilities in its production processes, etc. (dietary supplements); 21 CFR 111.75(a)(1)(i), 111.75(c), 111.65, 111.27(a)(3)(v), 111.27(d), 111.80, 111.553, 111.453, 111.15(b)(1)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm424445.htm
Urban Moonshine, Inc. Burlington, VT (11/20). Inspected 12/4/13-16/13. GMP deviations, adulterated, misbranded: FDA saw no evidence that the firm has established component specifications relating to purity, strength, composition, or limits on contamination for the components used in Nettles, Milky Oats and Immune Zoom. The master manufacturing record (MMR) the firm provided during the inspection for Immune Zoom was not specific to this product and batch size, and is the same MMR utilized to manufacture products other than Immune Zoom, such as Nettles and Milky Oats, etc. (dietary supplements); FDCA 402(g)(1), 403(q)(5)(F), 403(s)(2), 21 CFR 111.70(b)&(e), 111.205(a), 111.260
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm424244.htm
